Alto Neuroscience, Inc. announced today that its Phase 2b study of ALTO-100 in patients with major depressive disorder (MDD) did not meet its primary endpoint. The study, which was randomized, double-blind, and placebo-controlled, evaluated ALTO-100 in 301 adults with MDD, defined by an objective, memory-based cognitive biomarker.
The primary endpoint, assessed by a change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo, was not achieved. This outcome indicates that treatment with ALTO-100 did not demonstrate improvement in depressive symptoms relative to placebo in the biomarker-defined patient population.
Despite the lack of efficacy, ALTO-100 demonstrated a favorable safety and tolerability profile, consistent with previously reported studies. The company expects its current cash position to fund planned operations into 2027, supporting other upcoming clinical readouts for ALTO-203 and ALTO-300 in the first half of 2025.
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